The Recall Desk

Hazard

Lack Of Sterility recalls

1,417 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,417
Critical
3
Severe
1,048
Most recent
2026-07-29

Of the 1,417 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,048 (74%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all lack of sterility recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1401–1417 of 1417

  • SevereFDA (Drugs)·D-370-2013·2013-05-22

    Green Valley Drugs Recalls Human Chorionic Gonadotropin Injections for Sterility Concerns

    Green Valley Drugs is recalling Human Chorionic Gonadotropin (HCG) injections due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG 1500u/1.5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-377-2013·2013-05-22

    Green Valley Drugs Recalls L-Carnitine Injection Due to Sterility Concerns

    Green Valley Drugs is recalling L-Carnitine Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    L-Carnitine Injection, all strengths and all presentations including L-Carnitine 500 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-292-2013·2013-05-01

    HCG Lyophilized Powder Recalled for Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling HCG Lyophilized Powder 10,000 unit for Injectable due to lack of sterility assurance. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.

    Product
    HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-283-2013·2013-05-01

    BiMix Standard Injectable Recalled for Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling BiMix Standard Injectable due to lack of sterility assurance and quality control concerns.

    Product
    BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-274-2013·2013-05-01

    Axium Healthcare Recalls Triamcinolone Hexacetonide Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Triamcinolone Hexacetonide Injectable vials due to a lack of assurance of sterility and quality control concerns.

    Product
    Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-273-2013·2013-05-01

    Betamethasone Injectable Recalled Due to Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling Betamethasone Injectable due to lack of sterility assurance and quality control concerns.

    Product
    Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-119-2013·2013-01-09

    New England Compounding Center Recalls Isovue Vials Due to Sterility Concerns

    New England Compounding Center is recalling Isovue 200 mg/mL and 300 mg/mL vials nationwide due to a lack of assurance of sterility.

    Product
    Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-117-2013·2013-01-09

    New England Compounding Center Recalls Glycerin 100% Vials for Sterility Concerns

    New England Compounding Center is recalling 165 vials of Glycerin 100% PF due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-113-2013·2013-01-09

    Betamethasone Sodium Phosphate Injection Recalled for Sterility Concerns

    New England Compounding Center is recalling Betamethasone Sodium Phosphate injections due to a lack of assurance of sterility.

    Product
    Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-124-2013·2013-01-09

    New England Compounding Center Recalls Triamcinolone Vials Due to Sterility Concerns

    New England Compounding Center is recalling specific Triamcinolone vials nationwide because the company cannot guarantee the products are sterile.

    Product
    Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-052-2013·2012-11-21

    Sterile Products from New England Compounding Center Recalled Due to Sterility Concerns

    New England Compounding Center is recalling all of its sterile products because the company cannot assure that the products are sterile.

    Product
    All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1465-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    BIEST(80/20) 6.25MG/GM (1.25MG/0.2ML) I-CREAM 6 ML (5 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1593-2012·2012-08-22

    Franck's Lab Recalls Sterile Papaverine HCL Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile Papaverine HCL injectable vials because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    PAPAVERINE HCL **(10ML VIAL) 30MG/ML INJECTABLE 10 ML 100 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1591-2012·2012-08-22

    Franck's Lab Recalls Sterile Paclitaxel Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Paclitaxel injectable products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    PACLITAXEL 6MG/ML INJECTABLE 500 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1500-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 ML ( 1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1585-2012·2012-08-22

    Franck's Compounding Lab Recalls Morphine Sulfate Injectable Products

    Franck's Compounding Lab is recalling 92 units of morphine sulfate injectable products due to a lack of assurance of sterility.

    Product
    MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML 25 ML 30 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 50MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 15MG/ML INTRATHECAL 40 ML;
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1446-2012·2012-08-15

    Nephron Recalls Albuterol Sulfate Inhalation Solution Due to Sterility Concerns

    Nephron Pharmaceuticals is recalling Albuterol Sulfate Inhalation Solution because the company cannot ensure the product is sterile. The recall affects 56,028 cartons distributed nationwide and in Puerto Rico.

    Product
    ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide